Mental health emergency transport: the pot-holed road to care

Historically, police have had powers under successive mental health legislation to apprehend people with mental illnesses without a warrant. This is a widespread practice around the world and in all Australian states. Further, police are frequently the first point of contact for people with a mental illness in the Australian community, particularly after hours when mental health crisis team resources are limited.1 However, people living with mental illness are increasingly recognised as a vulnerable population with high rates of exposure to traumatic life events;2 and many are exposed to distressing experiences within mental health care systems. Being transported in handcuffs in a police vehicle has recurrently been reported as particularly distressing3 (see also John’s experience in the fictional scenario4). A submission to the Australian Human Rights Commission’s “Not for Service” inquiry summed up the experience within the context of perceived mental health service failures:

Because intervention comes so late, consumers and families report that once the police are involved and no matter how the police are, there is still a sense of not being treated with dignity . . . “I know when I get sick that I quickly lose insight and will resist treatment but I am sick and there I am being handcuffed by police. No other groups of people with an illness are treated like this. Why are we? Surely there can be a better way. I think it starts with me being able to say, I’m becoming unwell and clinicians taking me seriously”.5

Recent changes to legislation in New South Wales sought to reduce police involvement in mental health by expanding state coercive powers to paramedics and registered mental health practitioners. While paramedics are taking on more emergency mental health responsibilities, police involvement does not appear to have been substantively reduced. New ways of thinking about community mental health responses are required. The primary aim of this discussion is to explore factors that may contribute to ongoing reliance on police involvement in transporting people affected by mental illness, by examining the Mental Health Act and the ensuing interagency response to mental health incidents.

Current mental health legislation

Under the current Mental Health Act 2007 (NSW), police may apprehend and transport a person to a declared mental health facility (DMHF) for psychiatric assessment if the officer believes the person: is committing or has recently committed an offence; has recently attempted or is probably going to attempt to kill himself or herself or someone else; or will probably attempt to cause serious physical harm to himself or herself or someone else (s. 22(1)(a)); and that it would be “beneficial to the person’s welfare” to be dealt with under mental health, rather than criminal, legislation (s. 22(1)(b)). This is in keeping with the enacted mission statement of the NSW Police Force, which provides for “the protection of persons from injury or death . . . whether arising from criminal acts or any other way” (Police Act 1990 (NSW), s. 6(3)(b)). The Mental Health Act allows police to divert people whom they suspect have a mental illness to health system, rather than justice system, end points.

The remarkable revisions enacted in the 2007 Mental Health Act extended state coercive powers to NSW Ambulance paramedics (s. 20) and other accredited NSW Health practitioners (s. 19 and s. 23), authorising them to detain and transport people living with mental illness to a DMHF for assessment. Paramedics and mental health practitioners were given powers to use “reasonable force” (s. 81(2)(a)) and physical restraint (s. 81(2)(b)), and trained paramedics could administer sedation (s. 81(3)). Paramedics were given authority to request police involvement where there were serious concerns for safety (s. 20(2)), and both paramedics and mental health practitioners could request police assistance, where practicable (s. 21(1)).

Evaluating the outcomes of changes to the Mental Health Act

Statewide statistics provided by the NSW Mental Health Review Tribunal (MHRT)6 suggest that transport by police (under s. 22 of the Mental Health Act) has remained stable, at about 20% of all presentations to DMHFs. In contrast, transport by paramedics (under s. 20) has increased to 6% (Box). These data do not include transport by police under other sections of the Act.

The Ambulance Service of NSW has estimated that of all occasions of transporting people affected by mental illness in an ambulance, only about 2% per year involve involuntary transport (personal communication, Kevin McLaughlin, Manager Mental Health, Ambulance Service of NSW). This low scheduling rate may reflect NSW Ambulance policy that decisions undertaken by paramedics to transport a person against his or her will should be viewed as an option of last resort. Further, it may reflect people’s preference to be taken to the nearest health facility that has the resources to provide care, which may not necessarily be a DMHF if people agree to be transported voluntarily.

The NSW Police Force estimated that they responded to about 34 000 mental health-related incidents statewide in 2009.7 In 2012, there were 38 534 such incidents, with about two-thirds resulting in a designated police function under the Mental Health Act (eg, transfer from court, interhospital transport) and including about 12 000 occasions of police detaining people under s. 22 (data obtained by M I). In the 6 months to May 2013, police detained 6149 people under s. 22 of the Mental Health Act across NSW, according to the NSW Police database (Computerised Operational Policing System [COPS]; data obtained by M I). Police do not necessarily transport all people detained under s. 22. Increasingly, people detained by police are then transported by ambulance to a DMHF; however, no records of this are kept. Further, there is a significant discrepancy between the number of people detained involuntarily by police in 2012 recorded by NSW Police and the number recorded by the MHRT (12 000 v 3000, respectively) that challenges the veracity of the available data. High-quality baseline data are required for accurately estimating the extent of police and ambulance involvement in the transport of people with mental illness across regions, and for evaluating outcomes resulting from changes to policy.

Problems with the current legislation

Risk of serious harm is the guiding principle

Under the Mental Health Act, a mentally ill or mentally disordered person is a person who is suffering from mental illness (s. 14) and/or whose present behaviour is “so irrational” (s. 15) that immediate care, treatment or control is necessary to protect the person or others from serious harm. “Risk of serious harm” is the guiding principle in any decision by mental health practitioners, paramedics and police to invoke a non-consensual intervention under the Mental Health Act.

The most significant implication of the sole reliance on this criterion is that a person’s mental health must deteriorate to the point that they become a serious harm risk before intervention through non-consensual action is legitimate. At the point where a person living with mental illness reaches a point of risk of serious harm, the probability of police involvement appears to increase according to the severity of risk.

Lack of capacity is not taken into account

Decisional capacity refers in this context to the mental competence of a person to make his or her own health care decisions. Legally and ethically, it is argued that competence is essential for autonomy, as only competent decisions reflect a person’s free will.8 Two important assumptions regarding decisional capacity should be noted: first, capacity is not necessarily global to the person but may be relative to a situation or decision; and second, it is a threshold concept, perhaps best understood in terms of a degree of capacity.9 The formal assessment of capacity must be made by a trained clinician, but carers and people living with mental illness may become attuned to signs that a period of diminishing capacity may be approaching.

A strong proponent for the use of capacity as a criterion in mental health legislation, Ryan, argues that the loss of capacity is not an all-or-none phenomenon, and suggests that a range of supported decision-making processes, including advance directives, could be instigated.10 This may help fill the apparent gap in service provision between when a person loses decisional capacity and when they pose a risk of serious harm. Ryan and others have argued that using capacity to determine the threshold for non-consensual treatment would provide a legal and ethical justification for earlier intervention.10 Doctors, carers, mental health practitioners and people living with mental illness could activate a legal mechanism for non-consensual intervention for assessment before the onset of high-risk behaviour. In principle, this has the potential to increase the capacity of mental health services to assist people living with mental illness, and may reduce the necessity for emergency responses.

The Act embodies legal, not benevolent, paternalism

The current mental health laws have evolved from centuries-old English laws that originally served the purpose of protecting society (preventive detention).11 Over time, the focus became care and treatment for the person — benevolent paternalism (parens patriae)12 — by which “we decide for him as we assume he would decide for himself if he were of sound mind”.11

Under the current Mental Health Act, however, paternalism is based on criteria other than the individual’s own presumed choices. This legal paternalism, based on harm, is distinguishable from benevolent paternalism, which would be based on capacity. This is a disquieting ethical–legal contradiction deserving the attention of policymakers.

Implications for practice of the changes to the Mental Health Act

A memorandum of understanding (MOU) was developed between NSW Health, the Ambulance Service of NSW and the NSW Police Force to delineate interagency roles and responsibilities during a mental health emergency. It stipulates that police should be involved only in high-risk situations.13 Nevertheless, the capacity of the MOU to cover the complexities of real-world mental health emergencies is limited by practicalities — for instance, mental health practitioners may not be available after hours; there may not be onsite interagency agreement on the person’s presenting level of risk; nor may there be ready availability of an appropriate transport vehicle. Additionally, in the many regional and rural centres across NSW, the drive to the nearest DMHF may involve extreme distances and take a long time.

Advances in online technologies and the availability of videoconferencing call into question the transporting of people living with mental illness long distances for assessment. The Mental Health Emergency Care — Rural Access Program trialled the use of videoconferencing to provide rural and regional hospitals in western NSW with timely access to expert mental health assessments.14 Among other positive outcomes, there was a significant reduction in the referral rate (ie, transport) to the distant DMHF, from 73% to 52% of all admissions by the end of the 20-month study. The program has continued as usual practice at the trial site and is being extended to neighbouring areas.

A number of other strategies are being developed with the aim of limiting the occasions when police are the primary providers of transport for people living with mental illness and reducing police involvement to an interagency support role. For instance, NSW Health has developed a fabric mechanical restraint device that is now used by paramedics when physical restraint is required. This reduces the use of police handcuffs and caged vehicles, and enables clinical monitoring of the person during ambulance transport.

For people living with mental illness, access to voluntary inpatient services is an important consensual pathway to care; however, access is not universal. Regional and rural areas in particular are poorly served. For the foreseeable future at least, the pathway to inpatient assessment for many people continues to involve emergency transport to DMHFs. Limiting the need for police attendance may be achieved by developing a model of care that aims to prevent situations where police are involved in mental health interventions.

Ethics in practice: case scenario

In the accompanying scenario4 there is a point where John’s parents and his caseworker, Kate, are all concerned that John is showing signs of serious deterioration. At the point where Kate advises John’s parents that she cannot force John to receive care there may be strong ethical grounds for non-consensual intervention. It appears that John’s decisional capacity has been reduced by his illness, perhaps beyond the point where he could be considered competent enough to be self-determining. At this point, Kate could arrange for a clinician who is qualified to assess capacity to visit John to determine whether his decisional capacity is critically compromised. If so, the Mental Health Act could be invoked to transfer responsibility for care decisions temporarily from John to the state, to provide the care that John would presumably choose for himself were he of sound mind.

Conclusions

The issue of ongoing police involvement in mental health services beyond high-risk situations is vexed. Two major contributors to ongoing reliance on police involvement are the enacted risk-of-serious-harm criteria and rural and regional resourcing issues.

There is an ethical imperative for earlier intervention in mental health situations. While police will always need to attend situations involving high risk for any member of the community, an earlier, more therapeutic intervention is required for a person living with mental illness who is losing the capacity to determine his or her own health care needs. A legal mechanism for non-consensual assessment based on decisional capacity could be explored. People living with mental illness could be supported, during periods of capacity, to identify indicators of diminished capacity as key intervention points, and doctors making clinical assessments in chronic and potential first-episode psychosis could give serious consideration to capacity. Thinking about capacity at an earlier intervention point may reduce the number of people requiring an emergency response. Further, making telehealth programs available in more rural and regional areas could help minimise long-distance transport. The establishment of reliable incidence statistics for emergency mental health transport would enable accurate assessment of the effects of policy changes on practice.

Ideally, people living with mental illness should be able to access quality mental health services voluntarily, long before non-consensual intervention is required. Once voluntary options have been exhausted, the point at which a person loses decisional capacity may represent an earlier, more benevolent juncture for non-consensual intervention. Reaching the point of emergency services intervention in a mental health incident should be the last option along the pot-holed road to care.

Statewide statistics concerning people taken to a mental health facility under the Mental Health Act 2007 (NSW)7

	Police (s. 22),* no. (%)			Ambulance (s. 20),* no. (%)
Financial year	Admitted	Not admitted	Total†	Admitted	Not admitted	Total†	Total no. presentations‡

2008–09	2712 (80%)	682 (20%)	3394 (22%)	263 (99%)	4 (1%)	267 (2%)	15 496
2009–10	2536 (74%)	889 (26%)	3425 (23%)	494 (85%)	88 (15%)	582 (4%)	15 199
2010–11	2293 (71%)	940 (29%)	3233 (22%)	669 (69%)	301 (31%)	970 (7%)	14 566
2011–12	2150 (69%)	968 (31%)	3118 (20%)	742 (73%)	272 (27%)	1014 (6%)	15 765

* These data refer to the Mental Health Act ss. 20 (paramedics) and 22 (police) only and do not include mental health transports by police under other sections of the Act, including police assistance to ambulance (s. 21), doctors and accredited persons (s. 19), carers (s. 23 and s. 26), courts (s. 33), breach of Community Treatment Orders (s. 142 and s. 58), nor voluntary or informal transports by police or paramedics. † Proportion of total agency (police or ambulance) transports (under schedule) to total presentations at mental health facilities (NSW Health). ‡ Does not include people reclassified from informal to involuntary.

Potentially incapable patients objecting to treatment: doctors’ powers and duties

Occasions of potential involuntary detention of patients who refuse treatment are not limited to dramatic situations involving the police, with such unfortunate outcomes as John’s.1 Consider the following scenarios: in a coronary care unit, a man wants to discharge himself without explanation one day after having a myocardial infarction; in a general practice waiting room, a patient with a serious head injury makes for the door saying he can’t wait; in an emergency department, a young woman wakes up from a presumed overdose and demands to leave. In each of these scenarios, patients are refusing assessment or treatment, but there is reason to suspect that they may lack the capacity to refuse treatment or may suffer from a mental illness.

In this article, we present a clinically oriented guide to scenarios like these, grounded in a previously published detailed legal analysis.2 First, we describe a doctor’s powers when a patient is known to lack decision-making capacity (DMC) or is known to be mentally ill. Next, we suggest that when a person’s DMC or mental state is unknown, the law provides a limited justification to briefly detain a patient when there is a strong reason to suspect that he or she may lack DMC or be mentally ill, and when refusal of treatment may place the patient at risk of serious harm. Third, we review any duty of care that a doctor may have to act in these circumstances.

Legal powers when a patient is known to lack decision-making capacity or be mentally ill

The law places enormous emphasis on a competent adult’s right to self-determination, and an adult patient with “no mental incapacity has an absolute right to choose whether to consent to medical treatment” or refuse it.3 Most medical assessment or treatment of adults with DMC will only be lawful if it is consented to. Detaining a patient against his or her will may constitute false imprisonment.

In the New South Wales case, Hunter and New England Area Health Service v A, Justice McDougall acknowledged that when patients refused treatment, there were sometimes two conflicting interests: the competent patient’s right to autonomy; and the state’s interest in preserving life.4 In attempting to resolve this conflict, McDougall J had regard for Lord Donaldson’s comments from an earlier English case and said, all things being equal, “the individual patient’s right was paramount” but that “if there were doubt as to the individual’s expression of preference, ‘that doubt falls to be resolved in favour of the preservation of life’”.4

Under the law, all adults are presumed to have the capacity to consent to, or refuse, medical treatment unless and until that presumption is rebutted.4 A person lacks DMC to make a particular decision if he or she “is unable to comprehend and retain the information which is material to the decision . . . or is unable to use and weigh the information as part of the process of making the decision”.4 The fact that the decision may seem irrational is not, on its own, sufficient to overturn the presumption of capacity.3

Australian states and territories have guardianship legislation that provides some mechanism for substituted consent once it is clear that the person lacks DMC (Box). These statutes allow patients to be treated in an emergency, without substituted consent, where treatment is considered necessary to save the incompetent person’s life or prevent serious damage to the patient’s health. However, if it is not yet clear that the objecting patient lacks DMC — and incapacity is only suspected — these statutes do not apply.

Every jurisdiction in Australia also has mental health legislation that provides for the detention of people with mental illnesses to allow assessment and treatment (Box). Once patients are detained under these acts they may be given psychiatric treatment and, in some cases, medical treatment without the need for consent. Just as guardianship legislation provides no assistance in the management of a patient if incompetence has not been established, mental health legislation is unhelpful in the management of objecting patients if mental illness is suspected but there has been no opportunity for assessment.

Justification for restraining a patient when incapacity or mental illness is suspected

In some cases the courts have determined that it may be justified to restrain a person when it is unclear whether they lack DMC or suffer from a mental illness. In the 19th century English case, Scott v Wakem, a man with delirium tremens who was consequently likely to have been incompetent, and who had threatened to kill his wife, brought an action against the “medical man” who restrained him.5 The judge commented that, if at the time of the original restraint the person was likely to do mischief to anyone, the doctor would have been justified in restraining him, “not merely at the moment of the original danger, but until there was reasonable grounds to believe that the danger was over”.5

In Watson v Marshall, the Australian High Court considered a case where a former doctor brought an action for false imprisonment against the medical superintendent of a psychiatric hospital.6 The Court referred to Scott v Wakem and other cases7,8 and noted that, in those cases, the lawfulness of an act of restraint depended on the “overriding necessity for the protection of himself or others”.6

In these and several other cases, courts have recognised a justification for the “otherwise unlawful restraint” of a person who may be a danger to themselves and others for the purpose of an examination “by proper persons” or “until the regular and ordinary means can be resorted to”. However, this would apply only in circumstances of “obvious necessity” and “could not be extended to ordinary cases”.9

We feel that these cases provide a basis at common law for lawfully restraining a patient in circumstances where there is suspected incapacity and where the restraint is necessary for the protection of the patient or others. Restraint could be applied only as long as the necessity prevailed or until other means of consent could be resorted to.

Duty of care to provide advice, assess decision-making capacity and detain

Doctors owe a duty of care to their patients to provide advice, care and treatment. The care provided should be of a standard that would be widely accepted by peer professional opinion as competent professional practice. Doctors are also under a duty to provide patients with information that any patient would feel was relevant to the decision at hand and any other information that the doctor should have known would have been important to that particular patient (Box).10 When a patient refuses to wait for a full assessment, there is a duty to at least provide appropriate advice. In the NSW case, Wang v Central Sydney Area Health Service, the court found the health service negligent in failing to provide appropriate advice to a young man with a head injury who decided to leave an emergency department waiting room without waiting to be seen by a doctor.11

A number of cases suggest that there is also a legal duty to assess DMC where there is uncertainty about its presence and where there are potentially serious consequences if treatment is refused. Uncertainty may arise in circumstances where the nature of a particular injury (such as a head injury) or the person’s presentation (such as a reduced level of consciousness) suggests that his or her capacity may be impaired.

Ms B v An NHS Hospital Trust was an English case involving a 43-year-old woman with tetraplegia due to a cervical spine cavernoma, who sought withdrawal of artificial ventilation.12 The judge held that when there was doubt about the DMC of a patient, the doubt should be “resolved as soon as possible”, and that while the issue of capacity was being resolved, the patient should be cared for “in accordance with the judgment of the doctors as to the patient’s best interests”.12 Guidelines set out in another English case suggested that doctors should identify any problem with capacity as soon as possible and assess this as a priority. These guidelines also suggested that if there was “a real doubt as to capacity the issue should be referred for resolution by the Court”.13

In contrast to decisions involving medical illness, the courts have so far declined to find that doctors have a duty to detain a person whom they suspect may have lost DMC or require treatment due to a psychiatric illness.14–16 Nonetheless, the law does not appear to be settled in this area, and it is possible that future cases may find a similar duty exists.

Conclusion

The courts place a high value on personal autonomy. However, autonomy is lost where DMC is lacking and, if this is not recognised, individuals may be deprived of necessary treatment. In cases where there is good reason to suspect that DMC is impaired and treatment refusal may involve significant risk, there is a duty to clarify the situation as soon as possible. Breach of that duty may give rise to a legal action for damages.

The law in this area is not clear, reflecting the reality that situations involving possible loss of DMC and a doctor’s duty to act are often complicated and may require urgent action. The courts have acknowledged this and recommended that doctors act in the best interests of a patient until the ambiguity can be resolved. Using the reasoning we have laid out above, we suggest the following approach when faced with a patient who refuses assessment and attempts to leave the hospital.

If there are no factors to suggest the patient lacks DMC or suffers from a mental illness, or if there are such factors but there is no foreseeable risk of serious harm to self or others, then the person should be given appropriate advice, and his or her decision to leave should be respected.

If, on the other hand, there is:

a known factor, such as a serious head injury, which may give rise to a lack of DMC; or recent behaviour such as an overdose which might suggest the presence of mental illness; or a decision to object to assessment or treatment that, in the context, is so unusual or inappropriate as to lead a reasonable person to suspect that the patient’s DMC may be impaired; and
a foreseeable risk of serious harm to that person or others; and
no less-restrictive way of clarifying the person’s capacity to refuse assessment or prevent the risk;

then, a clinician should detain a person for as long as necessary to minimise the risk and/or until “regular and ordinary means” can be resorted to.

There appears to be a limited legal justification to detain the patient, using the least amount of force possible and certainly no more force than is proportionate to the danger to be avoided. The regular and ordinary means would likely include an assessment, and in the event that the patient is found to lack DMC or suffer from a mental illness, provision of care under the appropriate legislative or common law provisions. In cases where there is genuine doubt that is unable to be resolved, clinicians should consider detaining the patient and seeking direction from the court or an appropriate tribunal.

Relevant state legislation

Providing mechanisms for substituted consent:

Guardianship Act 1987 (NSW)
Guardianship and Administration Act 2000 (Qld)
Guardianship and Administration Act 1993 (SA)
Guardianship and Administration Act 1995 (Tas)
Guardianship and Administration Act 1986 (Vic)
Guardianship and Administration Act 1990 (WA)
Guardianship and Management of Property Act 1991 (ACT)
Adult Guardianship Act 1998
Emergency Medical Operations Act 1973

Providing for the detention of people with mental illnesses:

Mental Health (Treatment and Care) Act 1994 (ACT)
Mental Health Act 2000 (Qld)
Mental Health Act 1986 (Vic)
Mental Health Act 1996 (WA)
Mental Health Act 2007 (NSW)
Mental Health and Related Services Act 1998
Mental Health Act 2009 (SA)
Mental Health Act 2013 (Tas)

Defining doctors’ standard of care:

Civil Liability Act 2002 (NSW), s. 5O(1)
Civil Liability Act 2002 (WA), s. 5PB(1)
Civil Liability Act 2002 (Tas), s. 22(1)
Civil Liability Act 2003 (Qld), s. 22(1)
Civil Liability Act 1936 (SA), s. 41(1)
Wrongs Act 1958 (Vic)
Civil Law (Wrongs) Act 2002 (ACT)*

* The standard of care in the Australian Capital Territory is different
(see s. 42): “a reasonable person in the defendant’s position who was in possession of all information that the defendant either had, or ought reasonably to have had, at the time of the incident”.

Uganda anti-homosexuality law challenged

The World Medical Association (WMA) has written to the President of Uganda to express its concerns about anti-gay laws introduced by the African nation, urging him to reverse the measures.

President Yoweri Museveni signed an anti-gay Bill in February that some are condemning as among the toughest laws against homosexual people in the world.

The Bill punishes gay sex with up to life imprisonment, a measure likely to send Uganda’s beleaguered gay community further underground.

The Ugandan law calls for first-time offenders to be sentenced to 14 years in jail. It sets life imprisonment as the maximum penalty for aggravated homosexuality, defined as repeated gay sex between consenting adults and acts involving a minor, a disabled person, or where one partner is infected with HIV.

President Museveni said scientists had written a report that found there was no proven genetic basis for homosexuality, citing it as a reason for the introduction of the Bill.

Chair of the WMA and former AMA President Dr Mukesh Haikerwal and the Secretary General of the WMA Dr Otmar Kloiber said that the science and ethics on which the Ugandan legislation is based is incorrect, and that the new law will detract from the many advances in health care made in Uganda.

The letter states that WMA leaders met Uganda’s Minister of Health early in March and appeared on Ugandan TV to voice their concern and state clearly that they believe the new law is violating what is now being seen across most of the world community as a basic human right.

Dr Haikerwal wrote that “the heinous crimes of child abuse and pedophilia are abhorrent and totally unacceptable but have nothing to do with sexual orientation but criminal actions”. He said that … “it is correct to state, clearly and unequivocally, we are not aware of any medical reason or fault for bi-sexual or homosexual behaviour. Further, it is highly questionable that homosexuality poses a public health risk.”

Dr Haikerwal said ultimately the Ugandan legislation must be reversed.

Late last week, Ugandan rights’ activists and politicians filed a legal challenge to overturn the law.

The Civil Society Coalition on Human Rights and Constitutional Law, which represents about 50 groups, filed the petition in the Constitutional Court, asking for the law to be annulled.

Since the introduction of the law the World Bank has postponed a $90m (£54m) loan to Uganda to improve its health services, and several European nations – including Denmark, Norway, the Netherlands and Sweden – have cut aid to Uganda to show their opposition to the law.

The sponsor of the law, MP David Bahati, insists that homosexuality is a “behaviour that can be learned and can be unlearned”.

Kirsty Waterford

Let us decide when and how to die, say older Australians

A large majority of older people want the right to control the circumstances and timing of their death, and can envisage a situation in which they would seek help to end their life, a survey has found.

But, suggesting that talking about death remains a taboo topic for many, almost 36 per cent of 1804 people aged 50 years and older surveyed by the Council on the Ageing (COTA) NSW admitted they had not discussed their end-of-life care wishes with anyone.
Encouragingly, the online survey found that an overwhelming majority of older people (85 per cent) judged themselves to be in good or excellent health, while just two per cent rated their health as poor.

As part of the study, participants were asked about access to health care, and almost 80 per cent reported driving to see their GP, highlighting concerns about the health implications for the elderly if they lose their driver’s licence.
Reflecting this, 20 per cent said better public transport was needed in order to improve access to their GP, while more than 43 per cent thought there should be greater co-location of health services.

Among older people, consistency in GP care was rated highly – more than 40 per cent said the most important aspect of GP visits was seeing the same doctor every time. A further 22 per cent thought having their diagnosis and treatment explained so that they could manage their recovery was most important, while 19 per cent rated prompt service most highly.

When it came to hospital treatment, almost 50 per cent of those surveyed considered that having their diagnosis and treatment explained so that they could manage their recovery was most important, while almost 34 per cent set highest store on being treated with dignity and respect.
In a sign of unease among many about current arrangements, more than a quarter felt palliative care did not provide a comfortable end to life.
Of those who had discussed their end-of-life wishes with others, 64 per cent reported they had had such a conversation with their partner or carer, 58 per cent said they had discussed it with their children, 34 per cent had talked about it with friends, 22.6 per cent had discussed it with their GP and 20.6 per cent had had the conversation with their lawyer.

Most commonly (55 per cent), people wanted to die at home, while 12 per cent wanted to pass away in hospital, and many (26 per cent) remained unsure.
What was clear was that most (76.8 per cent) wanted the right to decide where and when they would die, including the possibility that they might be assisted in ending their life.

It is the latest survey suggesting that there is considerable support in the community for euthanasia laws.
COTA NSW said the survey showed that “older Australians are willing and able to take a high level of control over their lives, including the final phase of their lives”.

Adrian Rollins

Red Cross no ordinary symbol

By Dr Michael Gliksman*

Many of us associate the image of a red cross with the provision of medical services or assistance.

This association is unsurprising given that this is often how the symbol is portrayed in the media and popular culture.

Unfortunately, it is not well understood that the symbol of the red cross – as well as the red crescent and red crystal – has special meaning and protection under Australian and international law.

The red cross, the red crescent and the red crystal emblems are used in war zones to indicate that a person, vehicle or building is not part of the conflict, but is providing impartial medical aid and assistance to wounded soldiers, prisoners-of-war or civilians.

Every day, the emblems are used for these purposes to save lives – not just of the people who require assistance, but also of the staff who put themselves in dangerous situations. It is for this reason that the emblem must be protected and understood universally as meaning ‘Don’t Shoot!’

The emblem can be worn by medical military personnel and religious military personnel, as well as Red Cross workers. Due to the importance of the emblems, their improper use in conflict situations can constitute a war crime.

The protected status of these emblems is enshrined in the Geneva Conventions of 1949 and their Additional Protocols. In turn, the emblems are protected under Australian law in the Geneva Convention Act 1957 (Commonwealth).

As outlined in this Act, use of the red cross emblem in Australia, without the permission of the Minister of Defence, is an offence.

Even the Australian Red Cross must have Ministerial approval to use the emblem, and then only within strict guidelines to indicate a link to the Red Cross/Red Crescent Movement.

Australian law also protects anything “so nearly resembling any of the emblems” of the Red Cross “as to be capable of being mistaken for” the emblems. This means that dark orange crosses or red crosses on backgrounds other than white also should not be used.

The idea for a universal protective emblem was created by the founder of the Red Cross/Red Crescent Movement, Swiss citizen Henry Dunant, who witnessed the horrors of the aftermath of the Battle of Solferino in 1857 and the inadequate medical assistance that was provided to the wounded.

Mr Dunant was inspired by the Swiss flag (white cross on a red background) as a symbol of neutrality, and switched the colours to create the first Red Cross emblem.

In recognition of these origins, and the potential for confusion, Australian law confers on the Swiss flag the same protection accorded to the red cross, red crescent and red crystal symbols. The legislation precludes the use of a white cross on a red background.

Australian Red Cross assists the Minister of Defence to ensure the red cross emblem is correctly used and understood by the Australian community.

Often, when Red Cross contacts organisations that are misusing the emblems, we are asked why protection of the emblem in Australia matters.

The conflicts where these symbols are used are so far away and unlikely to occur in Australia, so surely these small uses of the symbols couldn’t possibly make a difference?

The answer is that any use of the emblems outside their purpose dilutes their authority and power to protect during conflict.

Every country in the world is a party to the Geneva Conventions. By doing so, all have agreed that these are universal symbols of protection, and are to be understood as such everywhere.

There are a range of alternatives to the red cross that can be used.

For instance, the image of a white cross on a blue background is used in common street signs around Australia to indicate the location of a public hospital.
Similarly, a white cross on a green background is used for occupational health and safety and to indicate first aid.

Australian Red Cross works to build understanding in the community of the protective authority of the emblems.

We contact organisations who misuse the emblem to make them aware of the emblems’ meaning and their proper use.

Australian Red Cross asks for your assistance to ensure that the true meaning of the red cross emblem is upheld in Australia.

Not using the red cross emblem is a small but meaningful way to contribute to the safety of Red Cross workers and military medical personnel, as well as the people they are trying to protect.

If you notice an emblem misuse, please notify the Australia Red Cross so that we can continue our education work. Please email: emblemmisuse@redcross.org.au
For more information, please visit Australian Red Cross’ website: http://www.redcross.org.au/the-emblem.aspx

* Dr Gliksman is a member of the Australian Red Cross International Health Law Committee.

Liability in the context of misdiagnosis of melanoma in Australia

Malignant melanoma is a disease for which misdiagnosis may have very serious ramifications for both patients and clinicians. Given how uncertain and difficult the diagnosis of some melanomas can be, clinicians may well be apprehensive about their potential professional liability arising from claimed misdiagnosis or mismanagement of melanoma. A recent Supreme Court of New South Wales decision1 is one of few Australian cases to directly address this issue specifically in relation to melanoma. Coote v Dr Kelly exists in the context of recent High Court of Australia decisions relating to the common law of professional negligence in Australia. Therefore, it is important to examine the particular facts of the case, how it was decided and why, and whether the court’s decision can reasonably be reconciled with what is understood of melanoma diagnosis clinically and from evidence-based medicine as well as a subsequent appeal which resulted in an order for retrial. We emphasise the importance of early recognition of uncertainty in diagnosis and subsequent escalation, particularly where delayed diagnosis may affect survival. This article provides medical practitioners with a better understanding of the uncertainty inherent in the law regarding certain issues of causation in negligence cases, and gives some guidance on an appropriate standard of care in the diagnosis of melanoma.

Coote v Dr Kelly: the facts

In September 2009, a patient consulted his general practitioner about a lesion on the plantar surface of his foot, which was diagnosed and subsequently treated as a plantar wart. Despite repeated attempts at cryotherapy, paring and topical treatments to the lesion, it continued to enlarge and change in shape and colour over the following 18 months. During this time, the patient was seen by the same doctor and, subsequently, by two other clinicians, all of whom continued to treat the lesion as a plantar wart. By March 2011, the lesion was noted to have substantially increased in size and to have ulcerated. It was then excised and diagnosed histologically as an invasive acral lentiginous melanoma (ALM). The lesion had metastasised, and the plaintiff faced a poor prognosis. Proceedings in negligence against the initial treating GP were brought before the NSW Supreme Court. Despite some uncertainty about the initial appearance of the lesion, the court found that the GP had breached his duty of care by failing to perform a biopsy on the lesion at an earlier stage; had he done so, it may have led to an earlier diagnosis of ALM. However, all the elements for negligence were not established. There was insufficient evidence to show that the breach of duty had caused the ultimate harm that befell the patient and, specifically, that an earlier diagnosis of ALM would have prevented the metastasis and subsequent poor prognosis.

Standard of care and breach of duty

Judicial findings

The court determined that the appropriate clinical standard of care was not met. A breach of duty of care was established, which was held to constitute the GP’s failure to observe a small black mark in the lesion at the initial consultation. The court determined that this ought to have drawn the attention of a reasonably competent practitioner to the need for further investigation. However, the New South Wales Court of Appeal has ordered a retrial (pending) on the basis of both flawed reasoning leading to the original conclusion of breach of duty, and flawed reasoning that such a breach, if it occurred, could nevertheless not be proven on the balance of probabilities to have caused the patient’s loss by using evidence of population-aggregated survival statistics.2

Commentary

Certain melanomas are inherently difficult to diagnose clinically, particularly those not fulfilling the classical ABCD criteria (asymmetry, border irregularity, colour variegation, and diameter > 6 mm).3 In one study, nodular, desmoplastic and ALM subtypes were not only associated with rapid and aggressive tumour growth but were also more likely to be clinically atypical.4 That is, they were more often amelanotic, symmetrical and elevated, with a regular border. Diagnostic features of these atypical melanomas are less effectively taught, and timely and accurate diagnosis presents a major challenge, particularly in the general practice setting.

Given the difficulties inherent in diagnosis, misdiagnosis of an atypical melanoma should not necessarily be considered to be a breach of a reasonable standard of care, especially given that GPs may see very few of these lesions during their careers. Whether a misdiagnosis constitutes a breach of duty of care is determined by a court on the basis of the admissible evidence, including expert peer professional opinion. In this case, the plaintiff’s evidence that there was pigmentation of the lesion at the initial presentation was critical in determining whether a breach of duty had occurred. In the absence of comprehensive clinical notes, it was difficult for the defendant to establish that there was no pigmentation at the initial presentation. All the clinicians involved in this case agreed that if there was pigmentation of the lesion, further investigation would have been warranted, as this might have indicated a diagnosis other than that of a plantar wart. The importance placed by the court on the presence or absence of pigmentation in determining the appropriate response of a reasonably competent practitioner is interesting and emphasised in the appeal judgment.5 It was largely based on the expert opinions provided. While the presence or absence of pigmentation may be an appropriate diagnostic clue, it is only one part of the broader clinical picture. The courts may tend to lend it excessive weight. Pigmentation alone should not dispose of the question of breach of duty of care. A more reliable clue to misdiagnosis may well be failed response to treatments that have been tried.

Repeated failed non-definitive treatments were continued by multiple clinicians, which allowed a significant amount of time to pass without the patient being referred to a clinician with peer-recognised specialist qualifications in the diagnosis and management of skin disease. On the evidence available, we consider that it was not the misdiagnosis per se that amounted to a breach of duty of care, but the lack of recognition of uncertainty and a failure to appropriately refer the patient or conduct further investigations once treatment failure became apparent. Definitive biopsy or escalation of care by referral to a specialist may each have averted the breach in this case.

From a clinical perspective, this reinforces the importance of accurate and precise documentation and personal communication with other clinicians. A change in presentation or a pattern of unsuccessful treatment, and hence uncertainty in diagnosis, can thereby be identified and acted on.

Causation and prognosis

Judicial findings

The court of first instance held that the evidence was insufficient to prove that an improved prognosis was probable, rather than possible, had the patient’s ALM been diagnosed and treated at first presentation. In the absence of proven causation of damage, despite a proven breach of duty of care, the court rejected the claim in negligence.

Commentary

The relationship between delay in diagnosis and poorer prognosis in progressive neoplastic disease may seem intuitive for many clinicians. The court’s decision on this point may therefore seem surprising. Indeed, the Court of Appeal rejected it.

The Breslow thickness of a melanoma at the time of removal is a major predictor of the likelihood of metastasis and therefore of overall prognosis.5 In Australia, the 10-year survival rate is 98% for lesions less than 0.76 mm thick but only 53% for lesions more than 3 mm thick; the outcome for people with distant metastasis is extremely poor (5-year survival rate, < 5%).6

Despite this, any direct relationship between delay in diagnosis and increased melanoma thickness remains controversial.6–9 It is recognised that melanomas vary widely in their rate of progression, particularly according to subtype, with certain subtypes such as nodular melanoma known to have a rapid vertical growth phase. One explanation for the apparent lack of a demonstrated relationship between diagnostic delay and tumour thickness is that tumour thickness at diagnosis may be more strongly related to the growth rate and biological aggressiveness of the tumour, rather than to the measured delay in diagnosis.9 Considering melanomas together as a homogeneous group, rather than as subtypes with widespread variability in rates of growth, has also been suggested to be a possible confounding factor for any measured association between thickness and delay in diagnosis.5 It therefore becomes difficult to retrospectively draw conclusions to determine the prognostic impact of misdiagnosis.

The court referred to the recent landmark High Court case of Tabet v Gett,10 where a claim of negligence resulting only in a loss of a chance of a better medical outcome was rejected. Tabet v Gett has authoritatively settled the point that the defendant’s negligence must be proven, on the balance of probabilities, to be the cause of the poorer outcome for the patient, compared with the expected outcome had the breach of duty not occurred. A loss of a chance of a better outcome is not of itself sufficient for a claim in negligence to succeed.

In general, in Australia, for there to be factual causation, it is necessary to prove that the harm to the plaintiff would not have occurred without the defendant’s breach. In Coote v Dr Kelly, the breach by the defendant was effectively that of misdiagnosing melanoma and delaying targeted treatment. The key question therefore became whether it could be proven that a difference existed between the prognosis for the patient at the time of the first presentation and the prognosis at the time that the melanoma was eventually diagnosed, and whether this difference was caused by the actions of his GP.

Much of the evidence relied on the interpretation by expert witnesses of epidemiological studies used for determining possible prognosis. The purpose of these studies is not to establish likely prognosis or to determine retrospective prognosis in any particular case. As a consequence, on the balance of probabilities, the first-instance court determined it was not proven that metastasis had not already occurred and, at the time of his initial presentation in 2009, this particular patient may have already had a poor prognosis.

The Court of Appeal expressly rejected the proposition that epidemiological studies cannot provide evidence sufficient to prove causation on the balance of probabilities of loss in an individual case. We respectfully agree with the Court of Appeal and strongly caution the medical profession against relying on an assertion (supported at first instance) that epidemiological evidence is incapable of supporting a legal finding of causation in any individual case. It is so capable. “There is nothing in Tabet v Gett . . . standing in the way of such a conclusion”.11

Melanomas with rapid vertical growth phases and aggressive histological features may have vertical progression rates > 0.5 mm in thickness per month4 and, in these cases, it is even more likely that delay in diagnosis may lead to a significant decline in prognosis. The importance of accurate and timely diagnosis of such lesions, in order to capitalise on a potentially short window of opportunity for improved prognosis, is a clinical imperative granted additional legal force by the recent Court of Appeal findings.

Conclusion

A high index of suspicion is always necessary when considering diagnoses that require early intervention to prevent significant harm to the patient. It may be difficult to diagnose atypical presentations of melanoma. By their very nature, such melanomas will have a higher rate of misdiagnosis.

Failure of initial treatment should trigger a recognition of uncertainty, an awareness of possible serious differential diagnoses and an understanding of the potential significance of error, with consequent escalation to specialist diagnostic and clinical care. Such recognition may be evident on the first consultation, or it may take several consultations before a pattern of uncertainty emerges. Consistency in documentation and communication among colleagues is essential where continuity of care is suboptimal. Recognising uncertainty and the need for escalation when recognised is a principle that applies to all aspects of clinical and histopathological practice. Its importance in the context of melanoma diagnosis, where delay may be a critical factor in the patient’s ultimate survival, is paramount. Establishing causation as a result of delayed diagnosis is often complicated, but it is possible, and epidemiological evidence may be employed to do it. If the litigation is not settled prior to retrial, the authors propose to publish further analysis of this important case as any judgment may become available.

Trials and tribulations in the removal of dextropropoxyphene from the Australian Register of Therapeutic Goods

In November 2011, the delegate of the Secretary of the Department of Health and Ageing gave notice that the Therapeutic Goods Administration (TGA) intended to remove dextropropoxyphene (brand names Di-Gesic and Doloxene) from the Australian Register of Therapeutic Goods.1

This followed a review of the safety and efficacy of medicines containing dextropropoxyphene. The TGA “determined that the overall risk of serious adverse reactions outweighs any benefits that may be provided by these medicines”.2 The main concern was the risk of sudden death from cardiotoxicity (not shared by other opioid drugs), in the setting of renal impairment, drug interactions and accidental or deliberate overdose.2–6

Evidence against dextropropoxyphene has been accumulating for over 30 years.3 The drug has been removed from the market by medicine regulators in the United Kingdom (2004), European Union (2009), United States (2010), New Zealand (2010) and elsewhere.2 Over a decade ago, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended removal of subsidies for dextropropoxyphene, and the Australian Medicines Handbook and Therapeutic Guidelines advised against using the drug.5,6 However, dextropropoxyphene remains on the market in Australia in 2013, 18 months after the TGA’s decision to delist it, owing to a series of legal appeals by the drug’s manufacturer before the Administrative Appeals Tribunal (AAT).1

Deregistration of dextropropoxyphene
in the AAT

The manufacturer of dextropropoxyphene in Australia, Aspen Pharmacare Australia Pty Ltd (Aspen), asked the Minister for Health and Ageing to reconsider the deregistration decision, but in January 2012 it was reaffirmed. The manufacturer then appealed that decision to the AAT. Both the manufacturer and the TGA accepted that the ultimate issue in the appeal was whether the “quality, safety or efficacy” of each drug “is unacceptable” within the meaning of section 30(2)(a) of the Therapeutic Goods Act 1989 (Cwlth) (the TG Act).

The AAT appeal was heard by Justice Kerr, President of the Tribunal, and Senior Member Dr Teresa Nicoletti. Teresa Nicoletti is also a partner at Piper Alderman, Founding Director of Pharmedica Consulting and a consultant to, and former regulatory and medical affairs manager with, several large pharmaceutical companies. In general terms, the appeal of the manufacturer, Aspen, was based around an argument that the drug was efficacious in some patients for whom other moderate analgesics did not work and that it could be used safely provided patients did not take excessive doses, and if the prescribing indications, contraindications and warnings were all carefully observed.1 The manufacturer also indicated [para 100]1 that it would be prepared to enter into contractual obligations with all pharmacies retailing dextropropoxyphene to supply it only on production of a signed statement from the prescribing doctor and countersigned by the patient about awareness of the risks. To obtain this stay, Aspen undertook to add significant safety warnings to the product information and consumer medicine information for Di-Gesic and Doloxene highlighting, among other things, that products containing dextropropoxyphene had recently been associated with substantial prolongation of the QT interval. Aspen also agreed to write “dear doctor” and “dear pharmacist” letters, in a form approved by the TGA, drawing attention to the additional safety warnings [para 11].1

Evidence was tendered to the AAT that despite regulatory decisions to remove dextropropoxyphene from general availability in the UK and US, it continued to be available under prescription in those jurisdictions [para 94].1 Rejecting arguments from the TGA’s counsel that the drug be made available only under the Special Access Scheme and to authorised prescribers (s19 TG Act) (it had only remained available after the UK ban on this sort of scheme), the AAT decided to remit the matter again to the Minister to see if agreement could be reached under s28 of the TG Act for the drug to remain available with “highly visible warnings and in blister packs designed to minimise the risk of misuse” [paras 99 and 103].1 The AAT also indicated that if the manufacturer still felt aggrieved by the TGA decision it could return to the AAT to continue its appeal. The manufacturer ultimately took up this option, and in April 2013 the AAT upheld the appeal in its final decision on this matter.7

Role of the AAT in Australian therapeutic
drug regulation

The AAT is usually the final hurdle for the TGA in regard to appeals against drug regulatory decisions in Australia. The role of the AAT is “to provide independent merits review of administrative decisions”.8

The Tribunal reviews a wide range of administrative decisions made by Australian Government ministers, departments and agencies . . . The Tribunal aims to provide a review mechanism that is fair, just, economical, informal and quick.8

Most of the AAT’s work relates to review of decisions made in regard to social security, worker’s compensation and taxation; only 12 of 5682 applications lodged before the AAT in the past financial year related to therapeutic goods, and appeals lodged by pharmaceutical companies often took over a year to resolve.9 Fighting litigation is expensive and time-consuming for the TGA; it takes resources away from its core roles, and the threat of legal appeal may undermine the capacity for regulators to make decisions solely in the best interests of public health.10,11

How well is the AAT equipped to make final judgments concerning the safety and efficacy of medicines? How well does the TG Act support the primary aim of promptly making scientifically sound decisions in the best interests of public health? Under the TG Act, the initial decision for deregistration of a medicine is made by the government on the grounds that safety, quality and efficacy are unacceptable. This can be contested by the manufacturer, who has the right to request the Minister to reconsider the decision; and then, if the manufacturer finds that outcome unsatisfactory, they can apply to the AAT for independent merits review of the decision.

In conducting that review, the AAT is not required to judge safety and efficacy by the usual standards set down for registering therapeutic goods by regulatory agencies worldwide — that is, on evidence of efficacy from clinical trials.12 The interim AAT judgment in this case stated:

There is no case law known to the Tribunal that suggests that the words ‘safety or efficacy’ should be construed otherwise than as ordinary English words, albeit read in the context of the Act as a whole

and refers to the Macquarie and Oxford dictionaries.1 Efficacy becomes “ability to bring about the intended result”. Evidence on efficacy presented to the AAT included patients’ and doctors’ opinions, 1998 Australian Drug Evaluation Committee minutes, and a 1984 publication from an industry-sponsored symposium involving reanalysis of small numbers of patients from previously published studies.1

Notably, the clinical trial data that would be a requirement for new drugs for which manufacturers are seeking TGA registration were not present in this case. Dextropropoxyphene gained registration through the process of “grandfathering” after the commencement of the TG Act, and the AAT did not compel the production of such data. In contrast, regulators today require that evidence of efficacy comes from clinical trials conducted to established regulatory standards.12

The TGA submitted in the 2012 AAT hearing that after the banning of dextropropoxyphene in the UK “there was a significant reduction in the rate of deaths by suicide and no commensurate increase in the number of deaths associated with other analgesics”1,4 (Box). However, the AAT judgment referred to “the straightforward and inescapable mathematical consequences” of these data being that there had been an increase in suicidal poisoning by other drugs.1 The AAT made the following comments about the expert witnesses who agreed with the TGA’s interpretation of these data:

. . . it was plain that both witnesses were highly resistant to conceding any point that might possibly be thought to assist the interests of the Applicant. This was particularly noticeable in both cases in respect of the Hawton et al evidence.1 [para 25]

The figure in the Box shows the data4 referred to in the judgment (the ban was phased in over the 3 years 2005–2007). The reduction in all drug suicides (362 fewer in 2008 than 2004) was greater than that from fatal poisonings attributed solely to dextropropoxyphene (196 fewer), suggesting that there may also have been a large additional reduction in mixed-drug overdoses. The frequency of other analgesic poisonings did not change significantly over 13 years (the rate varied between 209 and 287, but the linear trend was horizontal [− 0.5 deaths/year] and the 2010 data are equal to the long-term median [257]). Scientific thinking understands that minor year-to-year fluctuations are expected and are simply statistical noise rather than signals.

In another example, the manufacturer7 and the AAT [para 44]1 have also made much of the fact that there were more deaths recorded in the past decade in New South Wales coronial inquiries from codeine, paracetamol and tramadol than from dextropropoxyphene; however, no attempt was made to put that into perspective by adjusting for the vastly different rates of use.

The TGA has a statutory obligation under the TG Act to protect Australians against risks posed by unsafe, poor-quality and low-efficacy pharmaceuticals. In legal terms, the TGA administers the TG Act to ensure the quality, safety and efficacy of any therapeutic good supplied or produced in Australia. The TGA is responsible for licensing manufacturers, approving therapeutic products, and regulating such products once they enter the Australian market.

The developments in Australian law, arising from both policy and adjudicative determinations, potentially erode the ability of the TGA to firmly uphold its mandate. For example, the Australian Government’s decision to pay compensation rather than fight the civil litigation concerning the TGA’s action against Pan Pharmaceuticals has much broader implications for public health, to the extent that the decision could be interpreted as undermining the regulatory authority of the TGA.10

The final AAT decision overruled cancellation of Di-Gesic and Doloxene from the Register of Therapeutic Goods by the TGA but, despite this, summarised the AAT view on the key issues of efficacy and safety in the following statements:

Given that neither Di-Gesic nor Doloxene have been found to have exceptional efficacy and that the Tribunal has found that the risk of accidental overdose is real — such that it was common ground between the parties that the amount of DPP contained in a single blister pack of either Doloxene or Di-Gesic, if combined with alcohol, could in a vulnerable patient be sufficient to create a risk of sudden death — the Tribunal has concluded that the safety and efficacy of Di Gesic and Doloxene would be acceptable if, and only if, additional conditions were imposed which provide a high level of assurance that doctors will prescribe the products (a) only if therapeutically justified; (b) only after they have considered any contraindications and any recent changes to the patient’s clinical presentation or medical status; and (c) only after they have discussed with their patient the appropriate use of the products and the risks of overdose.7 (para 44)

and

. . . the safety and efficacy of Di-Gesic and Doloxene would be acceptable if, and only if, there were conditions put in place directed at minimising the risk that doctors might prescribe the product if a patient’s history indicates that he or she is at risk of intentional self-harm”.7 (para 45)

The AAT expectation that doctors and patients can comprehensively deal with the consequences of this decision contrasts with clear contemporary evidence that consistent delivery of care according to guidelines does not usually occur in the Australian health system.13

This case highlights the need to reconsider whether this appeal process appropriately serves the Australian public interest. Many developing countries around the world regard Australian registration of a therapeutic good as evidence that the drug has passed thorough scientific review.14 The current market for dextropropoxyphene is now almost entirely in such countries. When registration can be contrary to TGA advice and based around civil court proceedings rather than scientific interpretation of evidence, the international reputation of Australia’s drug regulatory system could be at stake.

Conclusion

Regulators need to consider legislation and precedents when undertaking regulatory actions on registered drugs, but ultimately this is a finely nuanced expert scientific judgement about evidence of risk and benefit.15 Evidence of harmful effects is often of lower quality and might take many years to accumulate. An alternative appeal process such as that used by the US Food and Drug Administration, based around independent expert panels and ombudsmen, might be better for reviewing disputed scientific evidence.16 The evidence put forward at appeals should be restricted to that generally accepted by regulatory bodies. The Commonwealth Parliament could also legislate to protect the TGA (and other scientific regulators) from legal challenges against good-faith actions designed to protect public safety; that is, when they are acting in the presence of substantial (but not conclusive) proof of significant harm. Such legislation might have safeguarded the TGA from actions in the Pan litigation; the TGA acted promptly to protect public health after discovery of widespread and serious breaches in manufacturing practice, only for taxpayers to lose over $122 million dollars in subsequent court cases.10

There was a very long lead time during which there were increasingly strong warnings to prescribers that the risk–benefit ratio of dextropropoxyphene was unfavourable2,5,6 before the TGA finally sought delisting (the last of the world’s leading drug regulatory agencies to do so).2 We are concerned that the Australian legislative and appeal framework and recent adverse litigation against the TGA contributed to this delay. While acting too early restricts drugs that are potentially still useful in some individuals, late action has often been measured in lives lost (thousands have died worldwide from dextropropoxyphene poisoning,3,4 and several deaths have occurred in Australia even as this appeal has unfolded [National Coronial Information System; unpublished data]). The TGA should be empowered to generate further evidence, or take prompt action on the balance of probabilities.17 There is only one benefit to the Australian public that could come from this current appeal — it should clearly highlight to our government the urgent need to revise the legal appeal processes that in our view inappropriately burden the TGA when it decides to take action to protect the Australian people.

Deaths from Co-proxamol* and other analgesic poisoning, and suicide by drug poisoning, United Kingdom, 1998–2010†

* UK brand name for dextropropoxyphene–paracetamol. † Graph drawn from data from Table 2 in: Hawton K, et al. PLOS Med 2012; 9: e1001213.4 Shading represents the period over which a ban on dextropropoxyphene was phased in.

Ethical and legal issues raised by cord blood banking — the challenges of the new bioeconomy

While human tissue has always had cultural, educational and scientific value, it is only in the past 40 years that tissue economies have begun to emerge.1 These economies have been driven by advances in technology that rapidly reversed our perception of human tissue as a useless by-product of treatment, to being a valuable and powerful source of wealth. Umbilical cord blood banking is an excellent example of this trend — what once was waste is now considered to be a wonder product that is collected, stored and traded in private and public markets.2 As a consequence, cord blood stem cells have become a focus of public, medical and scientific contest because of their uncertain ontological status (whether they are simply adult stem cells or share properties of both embryonic and adult stem cells), and because they have proven value as a source of haematopoietic stem cells for transplantation and more speculative value as a source of autologous stem cells for regenerative medicine.

Therapy and research: proof and potential

The benefits of cord blood stem cells in haematopoietic stem cell transplantation (HSCT) are clear. They are easily (non-invasively) collected and stored, they provide a rapidly available source of stem cells for HSCT, they extend the number of patients for whom HSCT is an option (because of their immunological immaturity), and they have been shown to give clinical outcomes equivalent to HSCT using bone marrow or peripheral blood stem cells.3 The benefits of cord blood transplantation rely primarily on the altruistic donation of cord blood around the world to an international network of more than 54 public cord blood banks, which collect, process, store and supply cord blood units (CBUs) for transplantation in Australia and internationally.

In contrast, the banking of autologous cord blood in private cord blood banks is based on the hope that it may, at some point in the future, be of therapeutic benefit in treating or curing any form of chronic or degenerative disease in its donor or in others. At present, this is entirely speculative. The likelihood that the infant, or other family members, will need access to their cord blood haematopoietic stem cells for established therapeutic indications is extremely low. For the most part, such use would be largely unnecessary, as most patients who need an autologous HSCT have haematopoietic stem cells collected from their peripheral blood or bone marrow when required.4 Despite the absence of indications for this use of cord blood, many parents elect to bank their child’s cord blood as a form of biological insurance, in the belief that such benefits may be recognised in the future — or at least to satisfy themselves that they have done everything in their power to guarantee their child’s wellbeing. There are now 225 private cord blood banks worldwide, storing nearly 1 million CBUs, which far exceeds the estimated 600 000 CBUs that are stored in publicly accessible cord blood banks.5

The emergence and rapid growth of private cord blood banks provides a significant challenge to the viability of public cord blood banks — a challenge that is likely to grow if evidence accumulates regarding cord blood stem cells’ utility in regenerative medicine.6 This challenge is both philosophical and practical. Philosophically, transplantation programs can only meet defined need and optimise equity in health care if sufficient numbers of citizens value social solidarity and make an altruistic decision to donate cord blood in the public interest. Practically, cord blood banks need to have a sufficient number of CBUs to maintain human leukocyte antigen variability, so that HSCT with sufficiently high cell doses and optimal human leukocyte antigen matching is available to those who need it.7,8

What makes these challenges so difficult is that they reflect fundamental moral questions regarding the design and delivery of health care systems, the rights and responsibilities of citizens in liberal democracies, the commitments that we have to generational fairness, and questions concerning ownership of human tissue. While some of these ethical and legal uncertainties are specific to cord blood (due, in part, to its origins in pregnancy), others are a feature of the challenges that arise in regulating emerging tissue economies.

In Australia, cord blood banking has emerged in a regulatory vacuum, and so has come to be governed by a patchwork of common law and legislative principles, including the doctrine of informed consent, legal and ethical notions of donation, and therapeutic goods law.9 This lack of direct regulation has undoubtedly created uncertainty regarding the status and management of cord blood and the obligations of both public and private cord blood banks.

Problems with consent: whose blood is being banked for whom?

Standard models of tissue donation assume that the process of informed consent must involve the person from whom the tissue is being taken (in living donation), or their representative (in some types of posthumous donation). Such an assumption is problematic in cord blood banking because it is not clear whether the mother or the child is the donor. As a practical matter, most collection occurs after consent from the mother either directly or on behalf of the child — but it is not clear, legally or ethically, that this is the most appropriate way of gaining consent. While consent has not yet been a subject of disagreement in this area, it is not hard to envision, in the modern era of the blended family, that there is potential for competing family claims should the therapeutic potential of cord blood materialise. And if situations arise where competing claims are made over stored cord blood, the nature of consent to storage and issues regarding proprietary interests (discussed below) will take central place in the resolution of any conflict.

Cord blood is genetically identical to the child but, depending on the method of collection and type of birth, may be collected from the mother or child, or from the cord when neither child nor mother is connected to it. There seems to be no dominant ethical or religious position as to who the donor is.10 Nor does the law provide any direct answer, as it views the placenta/umbilicus as being part of the mother for some purposes and part of the child for others.2 If one seeks an answer via genetics, one might argue that the child has a better claim, but it might be equally argued that other family members, including the father and siblings (both present and future), have claim to the cord blood, given the shared nature of the genetic information contained within it and its potential therapeutic uses.

We argue that these complexities require the consent process to be inclusive and representative of the different family interests in the cord blood. Thus, rather than relying purely on the birth mother to give consent, the process should, where possible, include the mother’s parenting partner. Further, it is our view that the consent given by the parents should expressly recognise that they are also consenting on behalf of the child.

Questions have also been raised regarding whether informed consent to private banking is a realistic possibility, given the extremely low likelihood of requiring one’s own stem cells for autologous transplantation later in life and the inevitably coercive nature of any decision that rests on assumptions about the best interests of children. It has been claimed that private banks in the United States have capitalised on the chance that families will overestimate the true likelihood of needing stored cord blood.11 Indeed, some would argue that advertising these services is exploitative, given the degree to which expectant parents are open to consider anything that may benefit their child (irrespective of the realistic expectation of that benefit) and the low likelihood that the cord blood will ever be used. However, there is no evidence that Australian private cord blood banks have engaged in any form of misleading or deceptive conduct in relation to their services. Indeed, our own view of Australian private cord blood banks is that their advertising seems rather modest, raising notions of insurance and explicitly acknowledging the low chance of the family ever needing to access the cord blood. In any event, the strictures of the Australian Consumer Law would be likely to prevent misleading and deceptive advertising.

Cord blood banking and property rights

As tissue economies have emerged, the common law of property has changed to recognise that people have property rights over their human tissue. Traditionally, the common law refused to recognise property rights in human tissue, unless the tissue had been preserved through some work or skill.12–14 This rule gave the property rights to whoever provided the labour or whoever paid for it to be done, which in the cord blood context gave rights to the public banks and to the purchasers of the services of the private banks. However, in the past 2 years, courts in both the United Kingdom and Australia have begun to recognise property rights in tissue that are not dependent on the work and skill exception, giving rise to rights to its possession, use, bailment (a property relationship), and protection from negligent storage.15–17 These cases indicate the potential for donors to have rights to deal with their tissue under both contract and tort law.

This broader recognition of property rights is a challenge to those who see human tissue donation as a form of gift that is devoid of proprietary rights. Indeed, the very notion of a gift in law is a property relationship where property passes hands without payment. Gifts can be given without conditions attached, but property law also recognises that gifts can be made conditionally in ways that preserve some rights of control and access for the donor.

Property law may be very useful in regulating cord blood banking because it creates a language for understanding conditional donation. Property laws may help to explain how cord blood could be gifted to a public bank on the condition that the donor parent(s) have the option to withdraw donated cord blood should the donor child or their sibling require the cord blood for their own medical use, and on the condition that the family are contacted before the cord blood is used in treatment or research (which is standard practice in some public banks). Property law also provides a model for understanding how, in the private banking context, a relative (such as a grandparent) could pay for the banking on the grounds that it is made available to a range of family members through a form of discretionary trust.

We believe that the current practice in the private banking industry has already effectively adopted property forms. The contracts for storage are bailments. The contracts also treat the cord blood as being held on behalf of an individual child or on behalf of the family group. This idea of holding property for the benefit of another is clearly a trust, where the legal title (held normally by the parents) is exercised for the benefit of the child (or family group). Once the child turns 18 years of age, most Australian contracts then state that the property then passes to the (now adult) child, which is again a classic trust mechanism.

In public banking, there appears to be more reticence to adopt property language, arguably because of its non-commercial focus. We argue that a public bank works just like a charitable trust — holding valuable property for the public benefit in pursuit of the charitable aims of improved health care. The usefulness of charitable trust laws is that they create a framework for donation and use of the cord blood.

While we recognise that property law is not a panacea for all regulatory woes, it does have the potential to provide tools for unpacking cord blood banking, as it provides a well established mechanism for recognising rights and resolving disputes between different interest holders.

Private, public or hybrid banking?

The complex issues surrounding cord blood banking and donation are not simply a function of the uncertain legal status of cord blood; they are also a function of the structure and function of public and private banks. Traditionally, public banks have stored donated cord blood for public use in allogeneic transplant programs and some (limited) types of research, while private banks have focused on storage for autologous treatment for the child donor. However, the line between public and private banking is becoming increasingly blurred.5 Many private banks now offer cord blood to matched family members of the child and are becoming increasingly involved in research projects. Public cord blood banks have generally acceded to requests to release donated CBUs for autologous transplantation or for use in related donor transplantation. But although there has been some convergence of practice, requests to use CBUs that have been donated to public banks to support allogeneic transplantation programs for research are more challenging.18

While those with opposing perspectives often build walls to protect their interests, this is unlikely to provide the best approach to accommodating both public and personal interest in cord blood. Indeed, the tensions that currently exist are likely to increase if the indications for autologous transplantation expand, or if evidence emerges that cord blood stem cells may have a therapeutic role outside of transplantation — be that in regenerative medicine or in immunoprotection against non-communicable diseases. As Han and Craig point out in this issue of the Journal,18 it is becoming increasingly clear that policy is needed to deal with requests for the release of cord blood for therapeutic and research purposes from public banks. Serious consideration needs to be given to hybrid models of banking that offer both public donation and private banking or make privately stored CBUs available to the public system should they be needed for transplantation.5

Conclusion

Cord blood banking is a challenging area to regulate. It throws up unique problems of consent and is complicated by a dual system of public and private banking. The emergence of property rights in human tissue is a further complication, but one that we feel will ultimately provide a means of untying some of these difficult questions and resolving the disputes that will inevitably arise concerning this valuable resource. Regardless of the way forward, it is clear that any regulation should be developed in an open and transparent manner. Regulation should be drafted in light of the concerns of both public and private banking and should be based on well informed public debate.19 We welcome efforts by AusCord and the Australian Bone Marrow Donor Registry to address these issues and believe that there is much to be gained from a broader public discussion about the goals of medicine and research and the importance of community and social solidarity.

Could a scheme for licensing smokers work in Australia?

In a recent article in PLOS Medicine, Chapman argued for the mandatory introduction of a licensing system for adult smokers,1 using age- and identity-verifying licences based on smart-card technology. Producing the licence would be a precondition to all cigarette purchases by adults who opted, after a 12-month phase-in period, to continue smoking. Retailers would be required to reconcile all stock purchased from wholesalers against a digital record of retail sales to licensed smokers. Together, these requirements would create a robust incentive for retailers to comply with laws that prohibit tobacco sales to children2 and would enable creation of a database of smokers and their cigarette purchases. These data would be extremely valuable for improving understanding of smokers’ behaviour and monitoring the effectiveness of smoking-cessation initiatives.

We agree with Chapman that a smokers licence could be an important next step for reducing smoking rates, but we differ about the optimal design features of such a scheme. In our view, a smoker licensing scheme needs to be as simple as possible and to focus on two clear goals:

to reduce unacceptably high rates of unlawful tobacco sales to children and adolescents; and
to make intelligent use of information about smokers’ purchases to help adult smokers quit.

We evaluated the key design features of Chapman’s proposal in terms of their relevance to achieving these objectives (Box). We would eliminate the non-core design features, resulting in a no-frills licence that would be easier to implement and administer, and easier to justify in light of the goals of the scheme. The non-core features described by Chapman included various licence categories based on a maximum purchase quota chosen by the smoker, a pre-licence test of the smoker’s knowledge about smoking risks, and a financial incentive for surrendering a licence by quitting smoking.

Reducing unlawful tobacco sales to children

It is an offence in all states and territories to sell tobacco to people who are under 18 years of age. However, these laws are widely flouted. The 2010 National Drug Strategy Household Survey found that 2.5% of adolescents aged 12–17 years were daily smokers; another 1.3% smoked less frequently.9 While most adolescents obtained cigarettes from friends or relatives, 31% of the tobacco smoked by adolescents was purchased from retailers or directly over the internet.9 A 2011 survey of Australian secondary-school students aged 12–17 years found that 50% of 17-year-old smokers and 21% of 12-year-old smokers believed it was “easy” or “very easy” to purchase cigarettes themselves.10 In an environment where nearly a third of tobacco smoked by adolescents is sourced through illegal sales by tobacco retailers, the requirement for retailers to verify that every pack sold is purchased by an adult is long overdue. Even if a smokers licence results in some increase in secondary purchasing by adults for children, the overall reduction in access by minors would be substantial and could eclipse any other single tobacco control measure currently under consideration.

In 2010, the average age for smoking initiation among people aged 14–19 years was 14.9 years.9 Reducing tobacco purchases by adolescents is central to the future course of the current epidemic of tobacco-caused disease, since most adult smokers began to smoke as children or adolescents, at a time when they were unable to purchase tobacco lawfully.

The administration of a smart-card licence would require all tobacco retailers to be identified and licensed.11 Four jurisdictions (South Australia, Western Australia, Tasmania and the Australian Capital Territory) already administer tobacco retail-licensing schemes. A retailers licence shares the goal of eliminating supply-side retailer violations, by making compliance with age-based restrictions and other controls a condition of the licence to sell tobacco products. However, the requirement for adults to present a licence when purchasing tobacco is a demand-side response that would complement supply-side controls, since it would enable health departments to audit tobacco retailers at any time. Tobacco retailers subjected to audit would be required to provide a reconciliation between the stock of tobacco supplied to them by wholesalers and the electronic data trail of retail sales to licensed adults.

In order not to undermine the integrity of a point-of-sale licence verification scheme, Australia would be wise to follow the United States, which, for different reasons, has substantially curtailed internet and mail-order sales by making tobacco products non-mailable matter through the US Postal Service, with limited exceptions.12 Non-US Postal Service carriers are permitted to accept internet orders for tobacco products and to send parcels containing tobacco, provided that the purchaser’s identity is verified through an identity authentication database at the time the order is placed and an adult verifies his or her identity with photo identification at the time of signing to accept delivery.12 In Australia, if mail-order and internet tobacco sales are permitted, they should be limited to adults in genuinely remote areas who present their smokers licence on collection. The integrity of these controls would be further enhanced by prohibiting direct, small-scale imports of tobacco products into Australia.

It has been estimated that in Australia in 2005, tobacco companies received over $15 million from children, while retailers received $9 million.13 The 2010 National Drug Strategy Household Survey found overwhelming support from the Australian public for stricter enforcement of laws against supplying minors (89% of those surveyed), and strong support for a licensing scheme for tobacco retailers (70%).9

Helping adult smokers to quit

Between 1985 and 2010, daily smoking rates among people aged 14 years or older halved from 30% to 15%. Despite this, there are still around 2.8 million daily smokers in Australia, and annual deaths from smoking continue to exceed deaths from alcohol and illicit drugs combined.14 Evidence shows that almost two-thirds of smokers regret their habit and wish they could quit.15,16 Could a smokers licence help them?

First, electronic monitoring of smokers’ purchases will enable health authorities to detect patterns and variations in smokers’ behaviour and to develop more sophisticated, individualised communications to assist smokers to quit. Second, it will enable rigorous evaluation of smoking cessation programs, ensuring that public health dollars are focused on evidence-based strategies that yield the best returns. Third, a smart-card licence will make it possible, for the first time, to gain a detailed understanding of smokers’ purchasing behaviour in response to industry incentives such as retail price discounts. Incentive payments and price supports paid by tobacco manufacturers to retailers are a largely invisible form of tobacco promotion and remain untouched by any tobacco laws in Australia.17,18 In the US in 2010, these payments accounted for $6.5 billion — 81% of all tobacco advertising and promotional expenditure.19,20

Objections to a smokers licence

“But it’s a legal product”

One of the enduring achievements of the tobacco industry is that, despite four decades of tobacco control, there has been little disruption to the underlying cultural assumption that a product — even a product that was responsible for 100 million deaths in the 20th century and, if current trends persist, will be responsible by 2030 for 10 million deaths each year21 — should be traded on market principles. We agree with Chapman that this notion needs to be quashed.

That does not mean, however, that tobacco should be banned, as some have advocated.22 Prohibiting tobacco at the present time would be likely to encourage a black market. Calls for a ban on smoking, and other “endgame scenarios”, are a distraction from the next generation of tobacco control policies — the constraints on supply and demand — that need to remain the focus as we work towards achieving a daily smoking prevalence that is a fraction of the current rate.

Loss of government revenue

The tobacco industry is likely to assert that a smokers licence will lead to widespread evasion of excise and goods and services tax by consumers, who will resort to small-scale, direct imports of tobacco products, rather than obtain a smokers licence. This claim seems implausible if a smokers licence is priced within reach of any adult who wants to obtain one. To minimise the risks of onselling and direct imports, it would be wise to charge no more than necessary for cost recovery under the scheme. The real savings will come from health care costs avoided by successful quitting. One option worth considering would be whether to completely waive the cost of the annual licence fee for smokers who were willing to disclose their mobile phone and email details to the licensing authority. This would create additional communication channels for smokers who agreed to benefit from carefully tailored smoking cessation support.

Big Brother

Requiring all smokers to present a licence, while tracking their cigarette purchases digitally, might be feasible in some countries, but will Australians tolerate it?

Australians’ distrust of the Australia card proposal, in the pre-internet era, revolved principally around “function creep” — the fear that government-controlled personal information would subtly, over time and without consent, come to be used for an expanding set of purposes. In this century, Australians have embraced mobile devices, online banking, Facebook, Twitter and membership in voluntary rewards schemes that collect data on individual patterns of retail purchase. Flybuys, for example, collects data on patterns of purchasing of over 10 million cardholders.23

By and large, Australians have opted for connectivity over data seclusion, relying on privacy laws and complaints schemes to guard against breaches of privacy. Australians seem to have few Big Brother fears about Medicare and the Pharmaceutical Benefits Scheme, although these are vast, national databases of the medical services we use and the drugs we are prescribed. As with other kinds of medical information, the data generated by a smokers licence should be rigorously protected under privacy and data security laws.

Stigma

Perhaps the most significant objection to a smokers licence is that it would exacerbate the stigmatisation of smokers. Collin, in his article answering Chapman, fears that smokers would feel they were being treated like “registered addicts”, and that, given the social gradient of smoking, a smokers licence would also amount to “censuring the poor”.24 He alludes to an important challenge for governments: tobacco control strategies have not been equally successful across all socioeconomic strata, and those who continue to smoke are more likely to have lower levels of education and income.9 This means that as smoking rates fall, all smoking-cessation interventions — especially those that aim to assist disadvantaged smokers — are at risk of being framed as “targeting the poor”. There is room for debate about the point at which policies intended to reduce socioeconomic disparities in health, such as higher tobacco taxes, cease to further this objective, and simply exacerbate poverty.25 On the other hand, if we want to make progress in reducing disparities in health, it is important not to point to the disparities themselves as grounds for doing nothing. It is also important for public health policies not to undermine the dignity of individuals, including those who wish to smoke. However, a smokers licence protects choice: it does not impose a smoke-free lifestyle on adults who cannot, or who choose not to, give up.

The bottom line

Australia remains a leader in tobacco control, having recently implemented the Tobacco Plain Packaging Act 2011 (Cwlth)26,27 and extended the Tobacco Advertising Prohibition Act 1992 (Cwlth) to ban tobacco advertising on the internet or using telecommunications devices. Other priorities have been signalled by the National Preventative Health Taskforce.28 They include:

mandatory reporting of advertising and promotional expenditures by tobacco manufacturers;
restrictions on price supports paid by tobacco manufacturers to tobacco retailers;
the elimination of all duty-free allowances for tobacco; and
restrictions on internet and mail-order tobacco sales.

There is evidence that the density of tobacco retailers in Australia is higher in areas of socioeconomic disadvantage,29,30 even after controlling for smoking prevalence.29 Research also suggests an association between the proximity of tobacco outlets to schools and adolescent smoking.31,32 Creating legal mechanisms to give local councils greater control over the location and density of tobacco outlets is a priority for tobacco control33 that could help to reduce an environmental contributor to socioeconomic health disparities.34

Once we get beyond the “shock of the new”, it is difficult to identify anything about a smokers licence that is particularly offensive or demeaning, given what we know about smoking. The concept of a smokers licence balances the reality of mass demand for tobacco in Australia against the fact that smoking is highly addictive and leads to the premature death, by about two decades, of one in two long-term smokers.35

Evaluation of key design features of Chapman’s smoker licensing scheme1

Possible advantages

Possible disadvantages

Core features

Smart card licence: adults wishing to purchase tobacco products must present a smart-card licence at point of sale to electronically verify their age and identity*

Individual patterns of tobacco purchases traced; data used for individualised quitting support

Data trail allows verification of whether all tobacco supplied to retailers was sold to adults

Data trail allows better understanding of smokers’ behaviour (eg, in response to retail price variations and discounts)

Data trail allows detailed tracking of smokers’ responses to smoking cessation programs and initiatives

Data trail allows monitoring of the impact of cigarette price discounting by retailers

Retail licensing controls extend accountability throughout the tobacco supply chain, from growers, dealers and manufacturers to retailers and adult smokers

May cause some smokers to feel they are “registered addicts” and add to the stigmatisation of smokers

Creates a historical database of adult smokers; recent activation of the licence implies current smoking. Privacy laws need to ensure data are protected and used only for authorised purposes

Scheme would need to cover pipe tobacco, cigars and waterpipes or risk creating market distortions in favour of these products, all of which share a significant risk profile3-5

Non-core features

Licence categories: licence holders would self-select into one of several categories of smoking intensity; licences with a higher purchase limit would cost more

Pre-commitment to a daily maximum would highlight to smokers their actual consumption; may motivate some smokers to quit or reduce consumption

Higher cost of licence with a higher consumption limit may encourage moderation

Some may overcommit to avoid the risk of running out of cigarettes, to moderate the impact of limits on bulk purchases, or to acquire flexibility to purchase tobacco for other people (eg, non-licensed smokers)

Purchase limits: licence holders could only purchase 2 weeks’ supply at a time, based on their daily maximum

Limiting bulk purchases may create a disincentive to sharing cigarettes, and to the social marketing of tobacco use

Some people (smokers and non-smokers) might choose a high licence category and onsell cigarettes in a way that undermines purchase limits

Annual renewal of licence

Cost of renewal would not be trivial; this may encourage some smokers to quit

Annual renewal would disproportionately affect people on low incomes (who smoke more and are more sensitive to price increases)

Annual renewal fee is an additional economic barrier to purchasing cigarettes; this may encourage onselling and result in hidden consumption, undermining the value of data obtained at point of sale

Licence surrender refund: smokers could permanently surrender their licence to receive a refund of all licence fees previously paid, with compound interest; after a 6-month “cooling off” period, the licence could not be taken up again

Refunding previous licence fees could provide a significant financial incentive to quit

Smokers who relapse after licence surrender could not lawfully purchase tobacco at retail and may resort to direct imports, informal sales or the black market

Smokers may strategically surrender their licence for a cash bonus, thereafter purchasing tobacco informally from other smokers (or non-smokers) who have a high licence limit

The licensing scheme would not be self-funding if smokers could claim a refund of all licence fees previously paid

Temporary licences available for purchase by international travellers verified as adults at ports of entry

Adds to overall complexity

Knowledge test: to qualify for a licence, adults must pass a knowledge test about the risks of smoking

Risk-minimising, self-exempting and rationalising beliefs are well recognised features of smoking behaviour.6 Most smokers know smoking is unhealthy, but are not well informed about the magnitude of their individual risk and the full range of possible harms. A pre-licence knowledge test may encourage some not to take up smoking; it also ensures that the decision to smoke is more informed

Consistent with tobacco industry preferences, the knowledge test requirement frames tobacco use as a “risky choice by informed individuals”, diverting attention away from the industry’s conduct

Shifts the focus away from supply-side controls (on tobacco manufacturers and retailers) to demand-side controls (on individuals)

Could be used in legal proceedings to exempt the tobacco industry from liability for harm caused by its products, based on the smoker’s “voluntary assumption of risk”7,8

Minimum purchasing age: over time, the minimum age for obtaining a licence to purchase tobacco might increase above 18 years

Adult smoking rates may fall significantly if the minimum age for eligibility for a licence is increased up to the age (eg, 23 years) after which it is unlikely that a person will take up smoking

Adults who become addicted to smoking while still ineligible for a licence will be forced to purchase tobacco informally (eg, through onselling, direct imports)

* Could be implemented nationally under Commonwealth law, by states and territories acting together, or it could be trialled by individual states. Additional regulations, including a ban on online and mail-order tobacco sales, would be best implemented at Commonwealth level. Data security and privacy laws to protect data generated at point of sale could be implemented at either Commonwealth or state levels.

On Australia’s doorstep: gold, rape, and injustice

Substantial involvement of health professionals is needed to stop further entrenchment of harm and suffering

Many Australians, like others in Western countries that are home to the world’s largest mining companies, benefit economically from extractive industries.
We want mine operations to be socially and environmentally responsible, and we expect our governments to fairly regulate corporate activity to prevent or mitigate harm.

But some communities in Papua New Guinea (PNG) bear the brunt of poorly regulated extractives projects, carried out with insufficient attention to their social impacts. When things go wrong, harms can be compounded by justice and health care systems ill equipped to respond effectively. Australian health professionals have expertise in many of the problems facing those living near PNG mines, and could have much to offer, working in partnership with local communities.

In March this year, women living near a remote PNG goldmine described to me how they had been brutally gang-raped by personnel associated with the mine. The Porgera mine — majority-owned and wholly operated by a subsidiary of Barrick Gold, a Canadian company with significant operations in Australia — generates great wealth. However, many women in the surrounding community are illiterate and poor, living in squalid conditions just a few feet from a mine that releases tailings waste into the environment. Traditional landowners have lost farming land to the mine’s operations, and many scavenge the mine’s waste to find gold scraps to sell for a few dollars.

These women are some of the many who have reported assaults to our team of human rights lawyers from Harvard and New York University Law Schools, as part of a 7-year project to document alleged assaults and to support victims seeking justice.1 Some of the women said they had been raped by five or more men at a time. Many said they were badly beaten; some were forced to chew condoms used during the assaults. Many women were afraid to report their cases to police, for fear of retribution or inaction. In addition, a number of the women whose assaults had become public knowledge were stigmatised, beaten by family members or divorced by their husbands.

The harm to these women has been amplified by gross failures in justice, and poor access to psychosocial support. For many years, the company and the government did not act on reports by non-government organisations (NGOs) exposing abuse, public since at least 2006. Amid mounting pressure, the company announced investigative and preventive measures in 2010, and the assaults appear to have significantly reduced since. Barrick also announced important efforts to address pervasive sexual violence in the region, including a local counselling service, although few women know about or access it.2,3 The company also created a remedy program for victims, although it has been highly problematic thus far, for reasons including its lack of clarity around compensation offers, and offers of items such as chickens (deemed insulting by the victims of severe sexual violence). Consultations excluded meaningful input from some key stakeholders (a local NGO, long-time international observers, and the victims themselves), and
the program does not address allegations of security guard violence against local men. Further, the requirement that to receive compensation, women must waive their right to sue Barrick, is problematic.4 The company has never disclosed how many employees it has terminated, and local police say that very few have been criminally prosecuted.

The sexual violence takes place in a complex web of other serious social, health and environmental concerns, almost all underaddressed. Significant concerns in villages around the mine include alcohol misuse, sexually transmitted diseases,
a lack of potable water and crowded living conditions. Residents often express fear that they and their land are being poisoned by the mine’s operations. Yet few independent scientific studies have been conducted, and the mine’s actual environmental impacts are largely unknown by residents. Locals’ concerns stem largely from the tailings and waste dumps, close to their homes. The community now perceives the impact of the mine to be so negative that they express a near-universal desire to be resettled far away.5

In Porgera many local residents (including children)
also handle mercury to extract gold from rock collected from the mine site. They have few other economic opportunitites and little education about mitigating their risk of harm from mercury exposure.

Australian experts are well versed in many of these issues, and partnerships with groups in Porgera could be invaluable. Multidisciplinary assessments and culturally appropriate programs are needed to address and prevent further entrenchment of harm.